AGC Biologics
Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
Program data pending ClinicalTrials.gov matching
· Last scored 2026-03-15
85.0
Signal Score
✓ FDA Inspections (1)
○ Clinical Trials
○ SEC Filings
✓ Press (6)
Quick Facts: AGC Biologics
- Signal Score
- 85.0/100 (as of 2026-03-15)
- Quality Compliance
- 100.0/100
- Headquarters
- Longmont, CO · Milan, IT · Copenhagen, DK · Chiba, JP
- Modalities
- CAR-T, Cell Therapy, AAV, Lentiviral
- Active CGT Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
- Scored By
- CDMO Signal — independent CGT manufacturing intelligence platform
Signal Score & Pillar Breakdown
Quality Compliance
100.0
FDA Inspections1 on record
Warning Letters0
Last InspectionVoluntary Action Indicated (VAI) (2025-04-18)
Operations
82.3
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Source: ClinicalTrials.gov
No clinical trial matches found for this manufacturer · Operational score requires ClinicalTrials.gov data
Programs
— no verified data
Sponsors— no verified data
ModalitiesCAR-T, Cell Therapy, AAV, Lentiviral
No clinical trial matches found for this manufacturer
Operational score requires ClinicalTrials.gov data
Data sourced from ClinicalTrials.gov, FDA, SEC EDGAR, and verified press only. No unverified estimates shown.
Financial Stability
75.0
Strong parent backing: AGC Inc. (Japan)
Source: SEC EDGAR, press monitoring
Subsidiary of AGC Inc.
SEC FilingsParent: AGC Inc.
Strong parent backing: AGC Inc. (Japan)
Capacity
72.0
3 CGT manufacturing sites
Broad modality coverage (4 modalities)
Facility expansion news detected
Sites: Longmont, CO, Milan, Italy, Chiba, Japan
Source: SEC EDGAR, press monitoring, company profiles
3 CGT manufacturing sites
StatusAvailable
3 CGT manufacturing sites
Broad modality coverage (4 modalities)
Facility expansion news detected
Sites: Longmont, CO, Milan, Italy, Chiba, Japan
Recent Press6 articles
3 CGT manufacturing sites
Broad modality coverage (4 modalities)
Facility expansion news detected
FDA Inspection History
2025-04
NAI
VAI
OAI
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2025-04-18 | Bothell, Washington | Blood and Blood Products | No | Voluntary Action Indicated (VAI) |
Source: FDA Data Dashboard · Retrieved Mar 20, 2026
Recent News 6 articles
AGC Biologics Expands Capacity at Berkeley, California Facility | Libero Quotidiano.it - Libero Quotidiano
AGC Biologics Expands Capacity at Berkeley, California Facility | Libero Quotidiano.it Libero Quotidiano
Continuous Manufacturing Market Trends and Global Forecasts, 2035 Featuring Key Players - AbbVie, Abzena, AGC Biologics, Boehringer Ingelheim, Corden Pharma, Glatt, Kaneka, Phlow, and Wuxi Biologics - Yahoo Finance UK
Continuous Manufacturing Market Trends and Global Forecasts, 2035 Featuring Key Players - AbbVie, Abzena, AGC Biologics, Boehringer Ingelheim, Corden Pharma, Glatt, Kaneka, Phlow, and Wuxi Biologics Yahoo Finance UK
Continuous Manufacturing Market Trends and Global Forecasts, 2035 Featuring Key Players - AbbVie, Abzena, AGC Biologics, Boehringer Ingelheim, Corden Pharma, Glatt, Kaneka, Phlow, and Wuxi Biologics - Yahoo Finance
Continuous Manufacturing Market Trends and Global Forecasts, 2035 Featuring Key Players - AbbVie, Abzena, AGC Biologics, Boehringer Ingelheim, Corden Pharma, Glatt, Kaneka, Phlow, and Wuxi Biologics Yahoo Finance
AGC Biologics Seattle Site Now Certified to Manufacture Biologics for Largest Pharmaceutical Market in South America - The Joplin Globe
AGC Biologics Seattle Site Now Certified to Manufacture Biologics for Largest Pharmaceutical Market in South America The Joplin Globe
AGC Biologics Seattle Site Now Certified to Manufacture Biologics for Largest Pharmaceutical Market in South America - Business Wire
AGC Biologics Seattle Site Now Certified to Manufacture Biologics for Largest Pharmaceutical Market in South America Business Wire
AGC Biologics Seattle Site Receives Anvisa GMP Certification - Contract Pharma
AGC Biologics Seattle Site Receives Anvisa GMP Certification Contract Pharma
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